Australian Tga Medical Device Regulations

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). This means that from 28 July 2021, devices that were previously …

Medical devices regulation basics - Therapeutic Goods …

https://www.tga.gov.au/medical-devices-regulation-basics

Overview of medical devices and IVD regulation

https://www.tga.gov.au/overview-medical-devices-and-ivd-regulation

The classification rules for medical devices are prescribed in Schedule 2 and Schedule 2A of the MD Regulations and outlined in the ARGMD. Classification of medical devices (not …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2017C00534

This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 1 July 2017 …

Standards, guidelines & publications (medical devices

https://www.tga.gov.au/standards-guidelines-publications-medical-devices-ivds

All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical …

Medical devices | Therapeutic Goods Administration (TGA)

https://www.tga.gov.au/products/medical-devices

Medical devices mainly work in a physical or mechanical way on the human body, or they’re used to measure or monitor it. Listen. Medical devices include a wide range of …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2022C00061

This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 18 …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2020C00112

Therapeutic Goods (Medical Devices) Regulations 2002 - F2020C00112 In force- Superseded Version View Series SR 2002 No. 236Regulations as amended, …

Medical device reforms: Regulatory changes

https://www.tga.gov.au/medical-device-reforms-regulatory-changes

As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates medical devices, and is responsible for implementing …

EU Medical Device Regulation: Implications for the …

https://www.tga.gov.au/sites/default/files/presentation-eu-medical-device-regulation-implications.pdf

On 25 Feb 2021 a new framework for the regulation of personalised (including custom-made) medical devices commenced in Australia ØBased on definitions and concepts …